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Bisphosphonate shows efficacy on intermittent regimen. (Schedule Called 'Impractical').
SAN ANTONIO -- For the first time, treatment with a bisphosphonate on an intermittent schedule has been shown to cut the incidence of osteoporotic fractures in postmenopausal women.
Treatment with ibandronate, a new bisphosphonate that is now under marketing review by the Food and Drug Administration for the treatment of osteoporosis with a daily dosing regimen, led to a significant drop in fractures in a controlled 3-year study of almost 3,000 women. With the intermittent-dosage regimen, women took the drug every other day for 24 days, followed by a treatment hiatus of about 66 days before they repeated the regimen cycle, Dr. Robert R. Recker reported at the annual meeting of the American Society for Bone and Mineral Research.
"This is the first real demonstration of the efficacy of an intermittent regimen with a bisphosphonate," commented Dr. Socrates E. Papapoulos, professor of endocrinology at Leiden (the Netherlands) University
Last February, an international team of researchers published a report that an intravenous dose of the bisphosphonate zoledronic acid, given once every 3 months, led to improvements in bone mineral density (N. Engl. J. Med. 346[9]:653-61, 2002). The new report is the first to test intermittent dosing using the benchmark measure of efficacy, a decrease in fracture incidence.
But the awkward ibandronate regimen used in the new study is unlikely to be readily adopted into clinical practice.
"The dosing schedule is too complicated and impractical. An intermittent regimen makes sense, but not one where patients always need to check a calendar," commented Dr. Michael McClung, director of the Oregon Osteoporosis Center in Portland.
According to a spokesman for Roche, one of the two companies that makes ibandronate and sponsored the new study, FDA approval for the intermittent regimen tested in the study is not being sought because it is "complex and not ideal for patients." However, Roche and GlaxoSmithKline, ...
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Source: HighBeam Research, Bisphosphonate shows efficacy on intermittent regimen. (Schedule...